Silicone Gel Breast Implants
FDA premarket approval P070004/S019 · decided 2019-12-18
Approval details
- PMA number
- P070004
- Supplement
- S019
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Silicone Gel Breast Implants
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Applicant
- Tiger Aesthetics Medical, LLC
- Date received
- 2019-08-20
- Decision date
- 2019-12-18
- Days to decision
- 120 days
- Decision code
- APPR
- Product code
- FTR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Franklin, WI
- Statement
- Approval for changes to the quality acceptance criteria used in the manufacturing process of Sientra OPUS Silicone Gel Breast Implants
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